Researching Heat and Yoga for Mood Enhancement

NCT06094088 | Recruiting DMC

• 1 other identifier: 2023p001916
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

This study will examine how doing heated yoga or non-heated yoga affects depression.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire-9 (PHQ-9)

  This measure is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. PHQ-9 scores range from 0 to 27. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.

  Weeks 0, 4, 8, and 20

Secondary Outcomes (4)

• The World Health Organization-5 Well-Being Index (WHO-5)

  Weeks 0, 4, 8, and 20

• Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)

  Weeks 0, 4, 8, and 20

• Ruminative Responses Scale (RRS)

  Weeks 0, 4, 8, and 20

• The Five Facet Mindfulness Questionnaire (FFMQ-15)

  Weeks 0, 4, 8, and 20

Study Arms (2)

Heated Yoga

EXPERIMENTAL

The heated (i.e., \~105°F with 40% humidity) yoga will be 90 minutes long and consist of 26 Hatha yoga postures and 2 breathing exercises. The class starts with standing postures for approximately 45-50 minutes, followed by a 2-minute savasana (or corpse pose on the floor) and the remainder of the 90-minute class is completed on the mat. All yoga teachers will be heated yoga certified.

Behavioral: Heated Yoga

Non-heated Yoga

ACTIVE COMPARATOR

The non-heated (i.e., room temperature \< 80°F) yoga will be 90 minutes long and consist of 26 Hatha yoga postures and 2 breathing exercises. The class starts with standing postures for approximately 45-50 minutes, followed by a 2-minute savasana (or corpse pose on the floor) and the remainder of the 90-minute class is completed on the mat. All yoga teachers will be heated yoga certified.

Behavioral: Non-Heated Yoga

Interventions

Heated Yoga BEHAVIORAL

Heated yoga described in arm/group description

Heated Yoga

Non-Heated Yoga BEHAVIORAL

Non-heated yoga described in arm/group description

Non-heated Yoga

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (18-65 years old)
• able to provide consent
• are able to read and understand English
• PHQ-9 score between 10-20, indicating moderate but not severe depressive symptom severity (27)
• Must have filled out the waiver for the community-based yoga studio prior to enrolling in the study.

You may not qualify if:

• have had a bone fracture or joint surgery in the past 6 months
• not able to walk freely or without difficulty
• have severe heart failure or lung disease
• participants endorse an item on the revised Physical Activity Readiness Questionnaire (PAR-Q+) and do not have approval from their treating physician (we will check in with treating physician in the event that participants endorse any item on the PAR-Q+)
• participants must have a physician responsible for their medical care
• are pregnant or planning to become pregnant
• no more than 6 yoga classes in the past 6 months
• have active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6)
• report manic symptoms (Altman Self-Rating Mania Scale score ≥ 6 (28))
• are on medications that make dehydration more likely (e.g., lithium, antipsychotics, insulin-dependent)
• active eating disorders or substance use disorders within the past 12 months
• antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit
• psychotherapy that has been initiated within the past 3 months
• willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study
• psychiatric hospitalization within the past year

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Tiny Blue Dot Foundation: collaborator

Study Sites (2)

Orange Door Collaborative

Cambridge, Massachusetts, 02139, United States

RECRUITING

Breathe Yoga Studio

Cambridge, Massachusetts, 02142, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Maren Nyer, PhD

CONTACT

617-726-8895; mnyer@mgh.harvard.edu

Louisa Sylvia, PhD

CONTACT

617-726-5855; lsylvia2@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-05

Locations

US (2)